FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071748 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Different approaches to brachial plexus block  
Scientific Title of Study   Ultrasound -guided brachial plexus block, a comparison between supraclavicular and costoclavicular approaches.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAFWA PULIKKAL 
Designation  JUNIOR RESIDENT  
Affiliation  GOVERNMENT MEDICAL COLLEGE, KOZHIKODE  
Address  DEPARTMENT OF ANAESTHESIOLOGY GOVERNMENT MEDICAL COLLEGE KOZHIKODE
Government medical college, kozhikode
Kozhikode
KERALA
673008
India 
Phone  9744185234  
Fax    
Email  safwajaleel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Biji KP 
Designation  Professor (CAP) 
Affiliation  GOVERNMENT MEDICAL COLLEGE, KOZHIKODE  
Address  drbijikp@gmail.com
Professor
Kozhikode
KERALA
673008
India 
Phone  9895131600  
Fax    
Email  drbijikp@gmail.com  
 
Details of Contact Person
Public Query  
Name  SAFWA PULIKKAL 
Designation  JUNIOR RESIDENT  
Affiliation  GOVERNMENT MEDICAL COLLEGE, KOZHIKODE  
Address  DEPARTMENT OF ANAESTHESIOLOGY, GOVERNMENT MEDICAL COLLEGE KOZHIKODE
Junior resident Major operation theater
Kozhikode
KERALA
673008
India 
Phone  9744185234  
Fax    
Email  safwajaleel@gmail.com  
 
Source of Monetary or Material Support  
Government medical college, kozhikode 673008 Kerala, India  
 
Primary Sponsor  
Name  SAFWA PULIKKAL 
Address  Junior resident Department of anaesthesiology Government medical college Kozhikode 673008 Kerala, India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SAFWA PULIKKAL  Government medical college, kozhikode  Major operation theater Department of anaesthesiology
Kozhikode
KERALA 		 9744185234

safwajaleel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE KOZHIKODE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S42||Fracture of shoulder and upper arm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA PS 1 AND 2 PATIENTS WITH UPPER ARM INJURIES UNDERGOING ELECTIVE AND EMERGENCY ORTHOPAEDIC PROCEDURES  
 
ExclusionCriteria 
Details  1. PATIENTS WITH NEUROMUSCULAR OR NEUROLOGICAL DEFICITS
2. PATIENTS WITH COAGULOPATHY
3. PREGNANCY
4. BMI>30
5. PATIENTS WITH ALLERGY TO LOCAL ANAESTHETICS
6. INFECTION AT SITE OF INJECTION
7. POLYTRAUMA
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
BLOCK PERFORMANCE TIME
 		 Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
BLOCK ONSET
BLOCK CHARACTERISTICS
 		 1.5 YEARS  
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [safwajaleel@gmail.com].

  6. For how long will this data be available start date provided 01-10-2023 and end date provided 01-09-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   THE STUDY AIMS TO COMPARE THE BLOCK PERFORMANCE TIME, BLOCK ONSE TIME AND BLOCK CHARACTERISTICS OF SUPRACLAVICULAR AND COSTOCLAVICULAR APPROACHES TO BRACHIAL PLEXUS BLOCK UNDER USG-GUIDANCE. 
IT WILL BE PERFORMED ON ASA PS 1 AND 2 PATIENTS WITH UPPER LIMB INJURIES UNDERGOING ELECTIVE AND EMERGENCY ORTHOPAEDIC PROCEDURES.

 
Close